Kornimate/medical-research-clean huggingface dataset:
the effect of ganglion sphenopalatine block versus placebo on persistent headache following covid-19 infection

Conditions: Headache; Covid19; Sphenopalatine Ganglion Block; Persistent Headache Following COVID-19

Summary: the purpose of this study is to evaluate the effect of the ganglion sphenopalatine block (spg block) on persistent headache following acute covid-19 infection.

adult patients with persistent headache following covid-19 infection will be enrolled in the study. the patients will be randomised into three groups; bilateral spg-block withto receive local anesthetic (lidocaine + ropivacaine), bilateral spg-block with placebo (isotone nacl) or bilateral "sham"-block with placebo (isotone nacl). primary outcome is hyperactivity in the sphenopalatine ganglion assessed by pain intensity (0-100mm on a visual analogue scale, vas) of the headache in standing position 30 minutes after block in the group ropicavain-lidocain and "sham".

Eligibility criteria:
inclusion criteria: * age \> 18 years * moderate to severe headache (nrs \>= 3) with self reported duration of minimum 6 hours during the past week as well as moderate to severe headache (nrs \>= 3) on the day of intervention. * onset of headache during or maximum 4 weeks after pcr-verified covid-19 infection. * headache must have persisted for at least 4 weeks following covid-19 diagnosis. exclusion criteria: * patients who cannot cooperate to the study * patients who does not understand or speak danish * allergy to the drugs used in the study * has taken opioids within 12 hours prior to intervention * history of migraine or persistent headache before covid-19 infection. * active covid-19 infection (defined by the danish goverment regulations, i.e. 48 hours after last symptoms (omitting long term effects) or 7 days after positive covid-19 test if no symptoms.
survival study of docetaxel and carboplatin as neo-adjuvant vs adjuvant chemotherapy in early stage nslc

Conditions: Non-small Cell Lung Cancer

Summary: the objective of the trial is to determine whether 3 cycles of tp (docetaxel plus cisplatin) after complete operation will improve survival when compared with 3 cycles of tp prior to complete resection for nsclc.

non-small-cell lung cancer (nsclc) accounts for approximately 80% of lung cancers diagnosed worldwide. surgical resection offers the best chance for cure for those patients diagnosed with early-stage disease, however, the vast majority of patients experience eventually relapse or metastasis. the rationale of neoadjuvant or adjuvant chemotherapy for early stage nsclc lies in the possibility of eradicating micro-metastasis disease, so it appears to improve survival by reducing the occurrence of distant metastases. meta analysis, calgb 9633, jbr 10 and anita trials have shown postoperative (adjuvant) ct after complete resection will prolong survival. on the other hand, depierre et al had conducted a trial to demonstrate preoperative (neoadjuvant ) chemotherapy in early stage nsclc appears to improve survival. we need a head to head trial to comparing neoadjuvant with adjuvant chemotherapy to answer which treatment model is better to early stager nsclc. based on proven activity and survival benefit in advance nsclc, docetaxel has been introduced into neoadjuvant therapy, even as a potential option in adjuvant setting. comparison: 3 cycles of tp after complete operation compared to 3 cycles of tp prior to complete resection for nsclc.

Eligibility criteria:
inclusion criteria: * histologically or cytologically confirmed stage ib-iiia non-small cell lung cancer patients,without previous chemotherapy, radiotherapy or target-therapy; * age from 18 to 75; * ps with ecoc 0-1; * adequate haematological and hepatic- renal function; * expected to live longer than 12 months; * the informed consent should be signed. exclusion criteria: * patients with small cell lung cancer; * already receiving any prior anti-cancer treatment; * pregnant women; * uncontrolled diabetes, mental disease; * hepatic and renal function failure; * the investigators believe the patient is not suitable to be enrolled in the study

Keywords: non-small cell lung cancer chemotherapy surgery neo-adjuvant adjuvant rct
a study of electromagnetic waves in the treatment of the advanced hepatocarcinoma

Conditions: Carcinoma, Hepatocellular

Summary: hepatocarcinoma (hcc) is the first cause of deaths due to cancer worldwide. more than one million two hundred thousand new patients are diagnosed each year. the prognosis of patients suffering from advanced hepatocarcinoma is poor with an average survival of less than six months. phase i data suggest that low levels of electromagnetic fields administered intrabucally with a portable and programmable device are a safe and potentially effective treatment for advanced cancer. the device is connected to a spoon-like coupler placed in the patient's mouth during treatment. patients with advanced hcc and limited therapeutic options will be offered treatment with a combination of frequencies.

hepatocarcinoma (hcc) is the first cause of deaths due to cancer worldwide. more than one million two hundred thousand new patients are diagnosed each year. the prognosis of patients suffering from advanced hepatocarcinoma is poor with an average survival of less than six months. therapies for hepatocarcinoma are limited. resection of the primary tumor is the therapeutic approach of first choice when possible. although this intervention results in long-term survival for some patients, only a minority of them are surgical candidates because of limitations due to tumor size, patient's overall condition or presence of hepatic cirrhosis. phase i data suggest that low levels of amplitude-modulated electromagnetic fields administered intrabucally with a portable and programmable device are a safe and potentially effective treatment for advanced cancer. the device is connected to a spoon-like coupler placed in the patient's mouth during treatment. patients with advanced hcc and limited therapeutic options will be offered treatment with a combination of hcc-specific frequencies. the patients will be offered ambulatory treatment, which will be administered three times a day for 60 min until disease progression or death.

Eligibility criteria:
inclusion criteria: * the patients must have a diagnosis of inoperable hepatocellular carcinoma. * the patients who have an afp level higher than 400 ng/ml and an appearance characteristic of cancer of the liver do not need histological confirmation. these patients must however have a negative serology for the antigen of surface of hepatitis b if serology for this antigen is positive, they must have a rate of afp higher than 4000 ng/ml. * presence of one or more lesions measurable(s) according to criteria's recist. exclusion criteria: * other anti-cancer treatments are not authorized during this study.

Keywords: carcinoma, hepatocellular electromagnetic fields
overtture: characteristics, treatment patterns and outcomes of patients with attr amyloidosis

Conditions: ATTR Amyloidosis

Summary: the overall aim of this observational study is to generate real-world evidence on the pre- and post-diagnosis disease journeys, including baseline characteristics, treatment patterns and selected clinical, economic, and humanistic outcomes (for example health related quality of life (hrqol), neuropathy impairment score, activities of daily living (adl) assessments) in patients with attr amyloidosis, and to better understand how the disease is presented.

this retrospective, observational, longitudinal, multi-country cohort study aims to describe characteristics, treatment patterns, and outcomes in attr amyloidosis patients. primary objectives: describe patient characteristics (for example demographics, family history of attr, key comorbidities and humanistic outcomes (e.g. health related quality of life (hrqol), neuropathy impairment score, activities of daily living (adl) assessments), treatment patterns, and disease outcomes. characterize and quantify the healthcare resource utilization (hcru) in attr amyloidosis patients who will be followed post-index until the end of follow-up. secondary objectives: describe demographics, clinical characteristics and hcru in attr amyloidosis patients prior to diagnosis.

Eligibility criteria:
inclusion criteria: * patients aged \>18 years at study index date and * a reported diagnosis code for amyloidosis or * a claim for attr-specific treatment or * a positive biopsy for amyloidosis and positive immunostaining result of biopsy for attr exclusion criteria: * evidence of primary (al) and secondary (aa) amyloidosis and/or * at least one claim/procedure code for stem cell transplant or at least two claims/procedure codes for chemotherapy and autoimmune disease drugs which may represent al (primary) or aa (secondary) amyloidosis treatments

Keywords: attr-cm, attrv-pn
the role of the locus coeruleus in age-related distractibility

Conditions: Aging; Alzheimer Disease

Summary: a growing body of research has highlighted the importance of frontal regions, at both the functional and structural levels, in age-related declines in attentional and cognitive processing. however, the underlying neurobiological pathophysiological changes in the brain that contribute to these declines are still largely unclear. the objective of this proposal is to investigate neural mechanisms of age-related attentional distractibility, focusing on the neural circuit initiated from the locus coeruleus (lc). in the current proposal, the investigators will test the hypothesis that the neural disconnectivity of lc with the salience network (sn) drives failures of ignoring distractors in older adults. the investigators will examine how lc-sn connectivity is associated with selective attention performance, and how improved lc-sn connectivity through a cognitive training program may lead to improved attentional performance.


Eligibility criteria:
inclusion: * healthy adult participants * no younger than 18 and no older than 75 yrs of age * ability to provide written informed consent exclusion: * history of surgery involving metal implants * possible metal fragments in the eyes * pacemaker * a history of claustrophobia * braces * weighing over 250 pounds * pregnant or possibility of being pregnant. * severe medical or psychiatric conditions (e.g., blind or deaf, head trauma) * learning disabilities or developmental disabilities
alcohol and neural cardiovascular control in binge drinkers

Conditions: Binge Drinking

Summary: this study evaluates the impact of evening alcohol consumption on sympathetic activity and baroreflex function in binge drinkers. our central hypothesis is that evening binge alcohol consumption will lead to sympathetic overactivity and blunted baroreflex function.

this study will recruit male and female binge drinkers who will participate in a randomized, cross-over, double-blind, placebo-based study to examine the impact of an evening of alcohol vs. placebo/fluid-control on autonomic and cardiovascular control at night and the subsequent morning. the study will utilize established techniques for assessing sleep (polysomnography) and autonomic/cardiovascular control (microneurography, beat-to-beat finger plethysmography, electrocardiogram, etc.). all subjects will undergo a familiarization night in the sleep laboratory prior to their first randomized test session with either alcohol or placebo/fluid-control. both men and women will be tested to address a secondary aim of determining the impact of sex (male vs. female) and ovarian cycle (early follicular vs. midluteal phase) on sympathetic neural responsiveness to evening alcohol in binge drinkers. finally, as a tertiary/exploratory aim, participants that have a respiratory disturbance index of ≥5 episodes per hour during the alcohol treatment will be asked to consider one additional overnight session where they will be randomly assigned to either continuous positive airway pressure (cpap) or sham-cpap for one additional night of evening alcohol consumption.

Eligibility criteria:
inclusion criteria: * men and women age 21 - 40 years * binge drinkers as defined by a pattern of consuming ≥4 drinks if female (≥5 drinks if males) in ≤ 2 hours on more than one occasion within the past 6 months, and at least once in the past 30 days. the national institute of alcohol abuse and alcoholism (niaaa) definition of a "drink" will be used. * women must be eumenorrheic and premenopausal with regular and consistent menstrual cycles (i.e., \~25-30 days ovarian/uterine cycles that include 2-7 days of menstruation) * willingness to abstain from exercise and caffeine at least 12 hours prior to any autonomic and cardiovascular testing, and abstain from alcohol 24 hours prior to any autonomic and cardiovascular testing (unless experimentally administered). exclusion criteria: * body mass index ≥ 35 kg/m2 * smokers * a physician diagnosis of diabetes * pregnancy * taking any cardiovascular medications * severe obstructive sleep apnea as determined by an apnea-hypopnea index of ≥ 30 episodes per hour * moderate-to-severe alcohol use disorder (aud) as determined by the diagnostic and statistical manual of mental disorders (dsm-v) * individuals suspected to have mutant alcohol dehydrogenase 2 (aldh2) isoenzyme as determined using a validated flushing questionnaire * women using hormonal contraceptives (i.e., oral, intrauterine, etc.) in the prior 6 months
efficacy of synchronous and asynchronous telerehabilitation in covid-19 discharges

Conditions: COVID-19; Telerehabilitation

Summary: investigators aimed to evaluate the effectiveness of exercise programs given by synchronous and asynchronous telerehabilitation methods in patients after discharge from covid-19.

fifty seven participants will be enrolled. participants will be randomly divided into 3 groups. for this purpose, patients will be recruited at the time of discharge from the hospital and two experimental groups with the same physical therapy and educational program will be carried out. participants in the control group will only educational program. participants in experimental groups will be followed using videoconference interviews from synchronous telerehabilitation methods and mobile application from asynchronous telerehabilitation methods at home. these participants will be given an 8-week exercise program. the exercise program will consist of physical exercises (aerobic and strength exercises) along with breathing exercises and the patients will be evaluated before and after the treatment. after treatment programs, the functional capacity, performance, and hemodynamic parameters of the participants will be evaluated. quality of life, physical activity level, anxiety-depression, and fatigue severity will also be evaluated with questionnaires.

Eligibility criteria:
inclusion criteria: * covid-19 patients in the subacute period discharged * be 18 years or older * having received oxygen therapy or mechanical ventilation support in the hospital * access to online interviews and web-based exercises with a secure internet connection * having sufficient speaking and hearing skills for telerehabilitation * volunteer to participate in research exclusion criteria: * unstable clinical condition * having had cerebrovascular disease, intra-articular drug injection or surgery of the lower extremities in the last 6 months * inability to walk independently, even with an assistive device * having serious neuromuscular problems * not being cooperative enough to answer and understand questionnaires and scales

Keywords: covid-19 telerehabilitation exercise program breathing exercises
dose of hepatitis b vaccines in non/low-response populations

Conditions: Vaccination; Complications, Reaction, Serum

Summary: an interventional study will be performed in subjects aged 1-65 years old to evaluate effects of different doses of hepatitis b vaccines in low or non-response population.

a randomized clinical study will be conducted to evaluate effects of different doses of hepatitis b vaccines in low or non-response population in china. 650 low or non-response subjects after hepatitis b vaccination will be enrolled under the premise of informed consent. 200 subjects aged 1-17 years will be divided into 3 groups and 450 subjects aged 18-65years will be divided into 4 groups. group 1/2/3 will receive 3 doses of vaccine on day 0,30 and 180, with 5ug/10ug/20ug hbs-ag respectively. group 4 will receive 1 dose of vaccine with 60ug hbs-ag, low or nonresponse subjects of which will receive the second dose by an interval of at least 28 days. all vaccinations will be done by specific study personnel, who do not take part in the assessment of safety or immunogenicity. adverse events will be recorded after vaccination and blood samples were collected at day 30 after each vaccination for antibody detection. the clinical program approved by the ethics committee will be performed by the researchers independently. inspectors designated by the sponsor will take meticulous on-site audits to ensure the safety specifications during the whole process of research.

Eligibility criteria:
inclusion criteria: * aged 1-65 years old * male or non-pregnant female volunteers * provide written informed consents before joining the trial * clinically healthy as determined by: medical history inquiring and physical examination * negative for hbsag,hbsab,hbcab,hbeag,hbeab within the past 1 year exclusion criteria: * no history of hepatitis b vaccine * receipt of immunoglobulin within the past 1 month * allergic to any ingredient of vaccine * history of serious side effects, such as allergies, hives, breathing difficulties, angioedema or abdominal pain * severe acute and chronic diseases * autoimmune disease or immune deficiency * axillary temperature \> 37.0 ℃ over the time of vaccination

Keywords: response vaccination
comparing the effects of different doses of dexamethasone to treat inpatient covid-19

Conditions: Covid19

Summary: this open label clinical trial is to evaluate two different doses of dexamethasone on the health outcome using world health organization ordinal scale at day 28 in hospitalized patients with covid-19.

the coronavirus disease 2019 (covid-19) pandemic is a serious global health threat. multiple antiviral or immunomodulatory therapies have failed to show any mortality benefit for patients with covid-19. dexamethasone was shown in prior studies to improve mortality and ventilator free days. however, it is unclear what dose of dexamethasone is most beneficial in hospitalized patients with covid-19. this randomized single center open label clinical trial is to evaluate two different doses of dexamethasone (20mg vs. 6mg) on the health outcome for hospitalized patients with covid-19. the intervention arm is dexamethasone 20mg daily for 5 days, followed by dexamethasone 10mg daily for 5 days. the comparator is dexamethasone 6mg daily for 10 days. three hundred participants will be enrolled. the primary outcome is clinical improvement using world health organization ordinal scale at day 28.

Eligibility criteria:
inclusion criteria: * age ≥ 18 years old * rt-pcr confirmed covid-19 infection * positive pressure ventilation (non-invasive or invasive) or high flow nasal cannula (hfnc) or need supplemental oxygen with oxygen mask or nasal cannula exclusion criteria: * underlying disease requiring chronic corticosteroids * severe adverse events before admission, i.e. cardiac arrest; * contraindication for corticosteroids; * death is deemed to be imminent and inevitable during the next 24 hours * recruited in other clinical intervention trial * pregnancy * patient on judicial protection

Keywords: covid 19
germ cell tumor and testicular tumor dna registry

Conditions: Germ Cell Tumor; Testicular Tumor

Summary: this study is being done to create a registry to help us learn more about germ cell tumors (gct) and other testicular tumors. the registry will include people with these tumors and also relatives and unrelated people without these tumors. this study will help us learn more about the prevention, diagnosis, treatment and outcome of these tumors. studying relatives of patients and people unrelated to patients with gct and other testicular tumors will help us understand why some people get these tumors and why some people don't.


Eligibility criteria:
inclusion criteria: case cohort * must be ≥ 18 years of age and * must be an english-speaker and * must have a diagnosis or suspicion of germ cell tumor and/or a testicular mass family member cohort * must be ≥ 18 years of age and * must be an english-speaker and * must be a blood relative of the proband. family members of probands are eligible. these individuals need not have a diagnosis of gct-tt, as they will be used for segregation analysis of suspected variants found in the proband. control cohort * must be ≥ 18 years of age and * must be an english-speaker and * must not have a personal history of cancer, with the exception of non-melanoma skin cancer, and * must not have a family history of germ cell tumor or testicular tumor and * must not be a blood relative of controls enrolled in this study exclusion criteria:

Keywords: 14-016
bladder catheters during ablation procedures

Conditions: Atrial Fibrillation; Catheter Ablation; Catheter Complications

Summary: inserting a bladder catheter during catheter ablation is standard practice at most institutions. unfortunately, bladder catheters are associated with adverse outcomes, including catheter associated cystitis, hematuria, dysuria, and urethral damage. the investigator proposes a prospective, randomized clinical trial comparing group a that will receive a catheter during the ablation procedure and group b that will not receive the procedure. the investigator hypothesizes the group receiving the bladder catheters will have a higher rate of complications.

(af) is the commonest arrhythmia worldwide and accounts for significant morbidity. the mainstay of treatment for drug refractory af is catheter ablation. a preponderance of evidence indicates better outcomes when this procedure is performed under general anesthesia; this is standard of care at our institution. however, for a variety of reasons including long procedure time, procedural intravenous fluid administration, and prolonged bedrest following the procedure, standard of care at our institution and others is for bladder catheter placement during the procedure (4). unfortunately, bladder catheters used during cardiac surgery have been associated with adverse outcomes, including catheter associated cystitis, hematuria, dysuria, and urethral damage( fortunately, the landscape of af ablation is changing rapidly, and procedure times are rapidly decreasing. improvements in three dimensional mapping technology has allowed for less reliance on fluoroscopy and allows for real time visualization of ablation lesions. improvements in ablation catheters have allowed for significantly reduced intravenous fluid administration during the procedure. the site has also adopted an expedited protocol for venous hemostasis following the procedure that involves a figure-of-eight groin stitch, allowing for earlier mobility and a shorter bed rest following the procedure. therefore, we question the need for routine bladder catheter placement during af ablation procedures

Eligibility criteria:
inclusion criteria: * all subjects presenting to the st. vincent ep lab for af ablation ability to sign informed consent exclusion criteria: * recent (within 1 month) cystitis, history of urinary retention or incontinence, prior bladder catheter associated complications, hematuria, chronic kidney disease (stage ii, iii, iv, or v), dialysis, prostate cancer, renal cancer, bladder cancer, expected procedure duration \>6 hours.

Keywords: urinary catheter catheter ablation procedures